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Federal Register/Vol. 77, No. 28/Friday, February 10, 2012/Rules Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Rules and Regulations 6971 DEPARTMENT OF HEALTH AND notice of proposed rulemaking Disease Control and Prevention, 1600 HUMAN SERVICES published elsewhere in this issue of the Clifton Road NE., Mailstop E–03, Federal Register. A significant adverse Atlanta, Georgia 30333; telephone 404– 42 CFR Part 71 comment is one that explains: Why the 498–1600. For information concerning [Docket No. CDC–2012–0003] direct final rule is inappropriate, program operations: Dr. Robert Mullan, including challenges to the rule’s Centers for Disease Control and RIN 0920–AA47 underlying premise or approach; or why Prevention, 1600 Clifton Road NE., the direct final rule will be ineffective Mailstop E–03, Atlanta, Georgia 30333; Establishment of User Fees for or unacceptable without a change. Filovirus Testing of Nonhuman Primate telephone 404–498–1600. DATES: The direct final rule is effective Liver Samples on March 12, 2012 unless significant SUPPLEMENTARY INFORMATION: AGENCY: Centers for Disease Control and adverse comment is received by April This preamble is organized as follows: Prevention (CDC), Department of Health 10, 2012. If we receive no significant I. Public Participation and Human Services (HHS). adverse comment within the specified II. Background ACTION: Direct final rule and request for comment period, we intend to publish III. Rationale for Direct Final Rule comments. a notice confirming the effective date of IV. User Fees the final rule in the Federal Register V. Services and Activities Covered by User SUMMARY: Through this Direct Final within 30 days after the end of the Fees Rule, the Centers for Disease Control comment period on this direct final VI. Analysis of User Fee Charge (Cost to and Prevention (CDC), located within rule. If we receive any timely significant Government) the Department of Health and Human adverse comment, we will withdraw VII. Payment Instructions Services (HHS) is establishing a user fee this final rule in part or in whole by VIII. Regulatory Analysis for filovirus testing of all nonhuman publication of a notice in the Federal IX. References primates that die during HHS/CDC- Register within 30 days after the required 31-day quarantine period for comment period ends. I. Public Participation any reason other than trauma. We are ADDRESSES: You may submit comments, Interested persons are invited to amending regulations to establish a identified by ‘‘RIN 0920–AA47’’: by any participate in this rulemaking by filovirus testing service at HHS/CDC of the following methods: submitting written views, opinions, because testing is no longer being • Internet: Access the Federal e- recommendations, and data. Comments offered by the only private, commercial rulemaking portal at http:// laboratory that previously performed www.regulations.gov. Follow the received, including attachments and these tests. This testing service will be instructions for submitting comments. other supporting materials, are part of funded through user fees. The direct • Mail: Division of Global Migration the public record and subject to public final rule does not impose any new and Quarantine, Centers for Disease disclosure. Do not include any burdens on the regulated community Control and Prevention, 1600 Clifton information in your comment or because the testing of non-human Road NE., MS–03, Atlanta, Georgia supporting materials that you do not primates for filovirus is a long-standing 30333, ATTN: NHP DFR. wish to be disclosed publicly. requirement and the amount of the user Instructions: All submissions received Comments are invited on any topic fee is consistent with the amount must include the agency name and related to this direct final rule. previously charged commercially. HHS/ docket number or Regulation Identifier II. Background CDC is therefore publishing a direct Number (RIN) for this rulemaking. All final rule because it does not expect to comments will be posted without Filoviruses belong to a family of receive any significant adverse comment change to http://regulations.gov, viruses known to cause severe and believes that the establishment of including any personal information hemorrhagic fever in humans and an HHS/CDC testing program and provided. For detailed instructions on nonhuman primates (NHPs). So far, only submitting comments and additional imposition of user fees are non- two members of this virus family have information on the rulemaking process, controversial. However, in this Federal been identified: Ebola virus and Register, HHS/CDC is simultaneously see the ‘‘Public Participation’’ heading Marburg virus. Five species of Ebola publishing a companion notice of of the SUPPLEMENTARY INFORMATION virus have been acknowledged: Zaire, proposed rulemaking that proposes section of this document. identical filovirus testing and user fee Docket: For access to the docket to Sudan, Reston, Ivory Coast, and requirements. If HHS/CDC does not read background documents or Bundibugyo. Most strains of Ebola virus receive any significant adverse comment comments received, please go to can be highly fatal in humans, and on this direct final rule within the http://www.regulations.gov. Comments while the Reston strain is the only strain specified comment period, it will will be available for public inspection of filovirus that has not been reported to publish a notice in the Federal Register Monday through Friday, except for legal cause disease in humans, it can be fatal confirming the effective date of this holidays, from 9 a.m. until 5 p.m., in monkeys. (http://www.cdc.gov/ final rule within 30 days after the Eastern Time, at 1600 Clifton Road NE., ncidod/dvrd/spb/mnpages/dispages/ comment period on the direct final rule Atlanta, Georgia 30333. Please call filoviruses.htm). ends and withdraw the notice of ahead to 1–866–694–4867 and ask for a Ebola hemorrhagic fever was first proposed rulemaking. If HHS/CDC representative in the Division of Global recognized in 1976, when two receives any timely significant adverse Migration and Quarantine (DGMQ) to epidemics occurred in southern Sudan schedule your visit. To download an comment, it will withdraw the direct and in Zaire. Since that time, multiple electronic version of the rule, access final rule in part or in whole by outbreaks have occurred, mostly in http://www.regulations.gov. publication of a document in the Central Africa, and all have been FOR FURTHER INFORMATION CONTACT: Federal Register within 30 days after For associated with high (45–90%) case- the comment period ends and proceed questions concerning this direct final fatality rates in humans (for an updated with notice and comment under the rule: Ashley A. Marrone, JD, Centers for VerDate Mar<15>2010 17:10 Feb 09, 2012 Jkt 226001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\FR\FM\10FER1.SGM 10FER1 wreier-aviles on DSK5TPTVN1PROD with RULES 6972 Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Rules and Regulations list see http://www.cdc.gov/ncidod/ As a result, on April 20, 1990, HHS/ caretakers (4). Since the implementation dvrd/spb/mnpages/dispages/ebola/ CDC published a notice in the Federal and strengthening of the 1990 special- ebolatable.htm). In these epidemics, Register requiring a special-permit for permit requirements for importing transmission of the disease originated or importing cynomolgus, African green, nonhuman primates into the United occurred in a hospital (often by and rhesus monkeys (5). To be granted States, the morbidity and mortality of contaminated needles) and was a special-permit, importers must submit imported animals has decreased from an followed by person-to-person a plan to HHS/CDC describing specific estimated 20% to less than 1% (10). transmission by individuals who were isolation, quarantine, and Since 1990, these laboratory tests have exposed to, or had close contact with communicable disease control been conducted by a single commercial blood or secretions from seriously ill measures. The plan must detail the laboratory. Recently, a number of patients. measures to be carried out at every step circumstances have arisen such that this The ecology, natural history, and of the chain of custody, from laboratory is no longer able to perform mode of transmission of Ebola virus in embarkation at the country of origin, the testing for filovirus required on liver nature, and of the related Marburg virus, through delivery of the NHPs to the specimens from monkeys that die are becoming more clearly understood quarantine facility and the completion during the HHS/CDC-mandated with the implication of bats as of the required quarantine period. quarantine. Further, HHS/CDC notes reservoirs. The incubation period for Additional requirements include that the reagents required for this testing Ebola disease is 5–9 days (range: 2–15 detailed testing procedures for all are not commercially available and days) but can be shorter with parenteral quarantined NHPs to rule out the production of the reagents requires a transmission. Disease onset is abrupt possibility of filovirus infection. When biosafety level 4 laboratory (BSL–4). A and characterized by severe malaise, importers demonstrate compliance with BSL–4 laboratory is also required during headache, high fever, myalgia, joint these special-permit requirements, part of the testing procedure. To our pains, and sore throat. The progression HHS/CDC authorizes continued knowledge, neither commercial entities is rapid and includes pharyngitis, shipments under the same permit for a nor Federal laboratories other than those conjunctivitis, diarrhea, abdominal period of 180 days. Certain components at HHS/CDC are planning to offer this pain, and occasionally facial edema and of the special-permit requirement have service. Because HHS/CDC has the jaundice. Severe thrombocytopenia can changed slightly in response to required laboratory facility, access to the occur, with hemorrhagic manifestations surveillance findings and the reagents, and experienced personnel, it ranging from petechiae to frank development of improved laboratory has started performing this testing when bleeding. Death occurs primarily as a tests.
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